Janssen Receives FDA Approval for INVOKANA

Janssen, of Johnson & Johnson, announced that the FDA has approved INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease. INVOKANA® is the first and only oral diabetes treatment approved with this indication.

"This FDA approval makes INVOKANA® the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death. It is an important step forward for patients and the physicians who treat them," said James List, M.D., Ph.D., Global Therapeutic Area head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "Not only does INVOKANA® enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events."

The CANVAS (CANagliflozin cardioVascular Assessment Study) Program evaluated the effect of INVOKANA® on CV risk in a broad population of more than 10,000 adults with T2D who had established CV disease (65 percent) or were at risk for cardiovascular disease with two or more risk factors (35 percent). Overall, treatment with INVOKANA® as compared with placebo in addition to standard of care reduced the combined risk of heart attack, stroke and CV death by 14 percent (events occurred in 26.9 vs. 31.5 participants, respectively, per 1000 patient-years; HR: 0.86; 95 percent CI: 0.75 to 0.97; p<0.0001 for non-inferiority and p=0.0158 for superiority). In patients with established CV disease, treatment with INVOKANA® reduced the combined risk of heart attack, stroke and CV death by 18 percent compared to placebo (events occurred in 34.1 vs. 41.3 participants, respectively, per 1000 patient-years; HR: 0.82; 95 percent CI: 0.72 to 0.95).

This FDA approval builds on recent consensus reports from the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) that support the use of INVOKANA® across a broad range of patients. For patients with T2D and clinical CV disease, the ADA recommends medication management with SGLT2  (sodium-glucose cotransporter-2) inhibitors that specifically have a proven cardiovascular benefit. AACE also notes that for appropriate patients, INVOKANA® has been shown to reduce major adverse CV events.

"Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes," said Ralph DeFronzo, M.D., professor of medicine and chief of the Division of Diabetes at University of Texas, Health Diabetes Center, San Antonio.4 "With this approval, INVOKANA® now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events."

This new indication also applies to the fixed-dose combinations of INVOKAMET® (canagliflozin/metformin HCl) tablets and INVOKAMET® XR (canagliflozin/metformin HCl extended-release) tablets.

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